Hypothalamic Obesity
Conditions
Brief summary
This study will evaluate the safety and efficacy of Tesomet (tesofensine + metoprolol) in subjects 18 years of age or older, with HO
Interventions
OTHERPlacebo
Inactive comparator
DRUGTesomet
Fixed-dose combination
Sponsors
Saniona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Subject and, if applicable, their parent or legal guardian must be willing to provide informed consent * Diagnosis of HO secondary to damage to the hypothalamus * Female subjects must be of non-childbearing potential * At least 6 months since completion of therapy (chemotherapy, surgery, or radiation with resulting injury to the hypothalamus and/or the pituitary) with stable disease and lack of recurrence * BMI 30.0 to 60.0 kg/m², inclusive * Documented stable body weight (gain/loss \<10%) for at least 90 days prior to Screening * Stable and well-managed pituitary replacement (eg, glucocorticoid, thyroid hormone, estrogen/progestin or testosterone, desmopressin, or growth hormone) for \>2 months prior to Screening * Male subjects who are sexually active must be surgically sterile Key
Exclusion criteria
* Females who are pregnant, breastfeeding, or actively intending to become pregnant during the study * Sitting BP that meets the following criteria after 5 minutes of rest at Screening: 1. Systolic BP \>145 mmHg or \<100 mmHg; or 2. Diastolic BP \>95 mmHg or \<70 mmHg * Type 1 diabetes mellitus * History of major depressive disorder within 2 years prior to Screening, or any history of other severe psychiatric disorder (eg, schizophrenia, bipolar disorder) * Uncontrolled endocrine disorders (eg, Cushing syndrome, Addison's, hypothyroidism, hyperthyroidism) * History of bulimia or anorexia nervosa * Use of prohibited medications, including current use of selective serotonin reuptake inhibitors / serotonin-norepinephrine reuptake inhibitors (SSRIs/SNRIs)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body weight (%) | Baseline to Week 36 | Percentage change in body weight |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body weight loss | Week 36 | Proportion of subjects who meet pre-specified thresholds for body weight loss |
| Body weight (kg) | Baseline to Week 36 | Change in body weight in kilograms |
| Waist circumference (cm) | Baseline to Week 36 | Change in waist circumference in centimeters |
| Body Mass Index (BMI) | Baseline to Week 36 | Change in BMI |
Countries
United States
Outcome results
None listed